Agency Information Collection Activities; Announcement of Office of Management and Budget Approvals, 52060 [2024-13638]
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52060
Federal Register / Vol. 89, No. 120 / Friday, June 21, 2024 / Notices
Articles Containing Active
Pharmaceutical Ingredient(s)
Considered to be Poorly Soluble in
Aqueous Media, That Exhibit Little to
No Systemic Bioavailability, and Are
Locally Acting.’’ It does not establish
any rights for any person and is not
binding on FDA or the public. You can
use an alternative approach if it satisfies
the requirements of the applicable
statutes and regulations.
II. Paperwork Reduction Act of 1995
While this guidance contains no
collection of information, it does refer to
previously approved FDA collections of
information. The previously approved
collections of information are subject to
review by the Office of Management and
Budget (OMB) under the Paperwork
Reduction Act of 1995 (PRA) (44 U.S.C.
3501–3521). The collections of
information in section 512(n)(1) of the
Federal Food Drug and Cosmetic Act (21
U.S.C. 360b(n)(1)) have been approved
under OMB control number 0910–0669.
guidance-regulations/guidanceindustry, https://www.fda.gov/
regulatory-information/search-fdaguidance-documents, or https://
www.regulations.gov.
Dated: June 17, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024–13690 Filed 6–20–24; 8:45 am]
BILLING CODE 4164–01–P
FOR FURTHER INFORMATION CONTACT:
Amber Sanford, Office of Operations,
Food and Drug Administration, Three
White Flint North, 10A–12M, 11601
Landsdown St., North Bethesda, MD
20852, 301–796–8867, PRAStaff@
fda.hhs.gov.
The
following is a list of FDA information
collections recently approved by OMB
under section 3507 of the Paperwork
Reduction Act of 1995 (44 U.S.C. 3507).
The OMB control number and
expiration date of OMB approval for
each information collection are shown
in table 1. Copies of the supporting
statements for the information
collections are available on the internet
at https://www.reginfo.gov/public/do/
PRAMain. An Agency may not conduct
or sponsor, and a person is not required
to respond to, a collection of
information unless it displays a
currently valid OMB control number.
SUPPLEMENTARY INFORMATION:
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket Nos. FDA–2023–N–4066; FDA–
2023–N–0918; FDA–2023–N–4259; FDA–
2023–N–4849; and FDA–2021–N–0471]
Agency Information Collection
Activities; Announcement of Office of
Management and Budget Approvals
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
III. Electronic Access
Persons with access to the internet
may obtain the guidance at https://
www.fda.gov/animal-veterinary/
been approved by the Office of
Management and Budget (OMB) under
the Paperwork Reduction Act of 1995.
Notice.
The Food and Drug
Administration (FDA) is publishing a
list of information collections that have
SUMMARY:
TABLE 1—LIST OF INFORMATION COLLECTIONS APPROVED BY OMB
OMB control
No.
Title of collection
FDA Recall Regulations ..........................................................................................................................................
Food Labeling Regulations ......................................................................................................................................
Export Certificates for FDA Regulated Products .....................................................................................................
Food Allergen Labeling and Reporting ....................................................................................................................
Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption—Agricultural Water ............................................................................................................................................................
Dated: June 17, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024–13638 Filed 6–20–24; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
ddrumheller on DSK120RN23PROD with NOTICES1
[Docket No. FDA–2017–D–0154]
Considerations in Demonstrating
Interchangeability With a Reference
Product: Update; Draft Guidance for
Industry; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of availability.
The Food and Drug
Administration (FDA, Agency, or we) is
announcing the availability of a draft
SUMMARY:
VerDate Sep<11>2014
17:46 Jun 20, 2024
Jkt 262001
guidance for industry entitled
‘‘Considerations in Demonstrating
Interchangeability With a Reference
Product: Update.’’ This draft guidance
describes considerations regarding a
switching study or studies intended to
support a demonstration that a proposed
therapeutic protein product is
interchangeable with a reference
product for the purposes of submitting
a marketing application or supplement
under the Public Health Service Act
(PHS Act). After considering any
comments received in the docket for
this draft guidance, we intend to revise
the final guidance for industry entitled
‘‘Considerations in Demonstrating
Interchangeability With a Reference
Product’’ issued on May 14, 2019, to
amend sections in that document
regarding the subject addressed in this
draft guidance.
Submit either electronic or
written comments on the draft guidance
DATES:
PO 00000
Frm 00051
Fmt 4703
Sfmt 4703
Date approval
expires
0910–0249
0910–0381
0910–0498
0910–0792
6/30/2027
5/31/2027
6/30/2027
6/30/2027
0910–0816
6/30/2027
by August 20, 2024 to ensure that the
Agency considers your comment on this
draft guidance before it begins work on
the final version of the guidance.
ADDRESSES: You may submit comments
on any guidance at any time as follows:
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
www.regulations.gov will be posted to
the docket unchanged. Because your
comment will be made public, you are
solely responsible for ensuring that your
comment does not include any
confidential information that you or a
third party may not wish to be posted,
such as medical information, your or
anyone else’s Social Security number, or
confidential business information, such
E:\FR\FM\21JNN1.SGM
21JNN1
Agencies
[Federal Register Volume 89, Number 120 (Friday, June 21, 2024)]
[Notices]
[Page 52060]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-13638]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket Nos. FDA-2023-N-4066; FDA-2023-N-0918; FDA-2023-N-4259; FDA-
2023-N-4849; and FDA-2021-N-0471]
Agency Information Collection Activities; Announcement of Office
of Management and Budget Approvals
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is publishing a list of
information collections that have been approved by the Office of
Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
FOR FURTHER INFORMATION CONTACT: Amber Sanford, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852, 301-796-8867,
[email protected].
SUPPLEMENTARY INFORMATION: The following is a list of FDA information
collections recently approved by OMB under section 3507 of the
Paperwork Reduction Act of 1995 (44 U.S.C. 3507). The OMB control
number and expiration date of OMB approval for each information
collection are shown in table 1. Copies of the supporting statements
for the information collections are available on the internet at
https://www.reginfo.gov/public/do/PRAMain. An Agency may not conduct or
sponsor, and a person is not required to respond to, a collection of
information unless it displays a currently valid OMB control number.
Table 1--List of Information Collections Approved by OMB
------------------------------------------------------------------------
OMB control Date approval
Title of collection No. expires
------------------------------------------------------------------------
FDA Recall Regulations.................. 0910-0249 6/30/2027
Food Labeling Regulations............... 0910-0381 5/31/2027
Export Certificates for FDA Regulated 0910-0498 6/30/2027
Products...............................
Food Allergen Labeling and Reporting.... 0910-0792 6/30/2027
Standards for the Growing, Harvesting, 0910-0816 6/30/2027
Packing, and Holding of Produce for
Human Consumption--Agricultural Water..
------------------------------------------------------------------------
Dated: June 17, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-13638 Filed 6-20-24; 8:45 am]
BILLING CODE 4164-01-P